Acute Effect of Teriparatide With Bisphosphonate or Denosumab on Bone Resorption
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 27
- 试验地点
- 1
- 主要终点
- Bone Turnover Marker (Blood Sample)
研究概览
简要总结
The aim of the study is to assess the relative antiresorptive properties of 2 osteoporosis medications when combined with teriparatide.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 45 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Must satisfy A and B and C below:
- •A. Women aged 45+
- •B. Postmenopausal
- •C. Osteoporotic with high risk of fracture
排除标准
- •History of significant hepatic, renal, cardiovascular, malignant disease, or conditions with impaired immune system
- •Current alcohol or substance abuse
- •Major psychiatric disorders
- •Abnormal calcium level, elevated PTH, vitamin D deficiency, or anemia
- •Known congenital or acquired bone disease other than osteoporosis
- •Current use or past use in the past 12 months of oral bisphosphonates
- •Current use or use in the past 3 months of estrogens, selective estrogen receptor modulators, or calcitonin
- •Use of oral or parenteral glucocorticoids for more than 14 days in the past 6 months
- •Any current or previous use of strontium or intravenous bisphosphonates
- •Sensitivity to cell-derived drug products or teriparatide
- •Extensive dental work involving dental extraction or dental implant within the past 2 months or in the upcoming 2 months
- •Inability to sit upright for 30 minutes
- •Esophageal abnormalities
研究组 & 干预措施
Denosumab 60mg subcutaneous injection
Each subject will receive one teriparatide 40-mcg subcutaneous injection at each study visit.
干预措施: Teriparatide 40-mcg subcutaneous injection (Drug)
Denosumab 60mg subcutaneous injection
Each subject will receive one teriparatide 40-mcg subcutaneous injection at each study visit.
干预措施: Denosumab Injection (Drug)
Alendronate 70mg weekly x 8 weeks
Each subject will receive one teriparatide 40-mcg subcutaneous injection at each study visit.
干预措施: Teriparatide 40-mcg subcutaneous injection (Drug)
Alendronate 70mg weekly x 8 weeks
Each subject will receive one teriparatide 40-mcg subcutaneous injection at each study visit.
干预措施: Alendronate Oral Tablet (Drug)
结局指标
主要结局
Bone Turnover Marker (Blood Sample)
时间窗: 8 weeks
The primary outcome was the between-group difference in the teriparatide-induced change in serum c-telopeptide from baseline to week 8.
次要结局
未报告次要终点
研究者
Benjamin Leder, MD
Principal Investigator
Massachusetts General Hospital